Swissmedic: How Medical Device Regulation Has Changed

Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which we will explore below. But firstly for context, a brief background on Swissmedic and the recent changes:

Switzerland has historically been able to access the EEA through mutual recognition agreements, which allowed it to use the EU’s old medical device Directives (MDD / AIMDD / IVDD). However, following a failed attempt between the EU Commission and the Swiss Federal Council to come to an agreement on a Mutual Recognition Agreement (MRA) that would allow companies under the MDR and IVDR to provide product on to the market in Switzerland, Switzerland became a “third” country as it relates to both the MDR and IVDR.

As a result of not having a MRA in place, non-Swiss manufacturers must now appoint a Swiss Authorized Representative (CH-REP) to place medical devices onto the Swiss market. Conversely, Swiss manufacturers must also appoint a European Authorized Representative to place devices on the EU market.

Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which are outlined below.

Step 1: Appoint a Swiss Authorized Representative

All manufacturers located outside of Switzerland (except manufacturers located in Liechtenstein which are not required to appoint a CH-REP) are required to appoint a CH-REP with a permanent address in Switzerland. For manufacturers of medical devices with CE Marked devices already on the market before the MDR date of application, the Swiss representative must be appointed immediately as all deadlines to appoint a CH-Rep have passed:

• • Class IIb implantable, Class III, and AIMD – December 31, 2021
  • Class IIb non-implantable, Class IIa – March 31, 2022
  • Class I, systems, and procedure packs – July 31, 2022

There are no differences in “grace periods” between EU MDR and MDD/AIMD “legacy devices.”

For manufacturers of In Vitro Diagnostics (IVDs) with CE Marked product already on the market before the IVDR date of application, a Swiss representative must be appointed by the following deadlines based on IVDR classification:

• • Class D IVDs – December 31, 2023
  • Class C, B IVDs – March 31, 2023
  • Class A IVDs – July 31, 2023

The AR (Authorized Representative) service will no longer cover Switzerland once the grace periods end.

Please keep in mind that although MedEnvoy can act as both your EU Authorized Representative and CH Representative, these are completely different and independent roles from each other.

Lastly, if you are entering a new product, e.g., a device which previously did not have a CE Mark,on the market into Switzerland, then you must appoint a CH-REP immediately, as the transition period does not apply. The CH-REP and manufacturer are required to put in place a Mandate identifying the company names and addresses of both the manufacturer and CH-REP. The CH-REP can submit the Mandate to Swissmedic,

Step 2: Identify a Swiss Importer

The Swiss importer is whichever entity within the supply chain that is the first to place the product on the market. The Swiss importer information must be supplied with the device, either on the device labeling, instructions for use, or in a document accompanying the device (which   could include: a delivery note, guarantee certificate, customs documents, or invoice). It is worth noting that Swissmedic does not require that the document accompanying the device have to reach the end user. Swiss importers are also still required to identify themselves with MDD/AIMDD CE marked products, also known as, ‘legacy’ devices. Swiss importers of MDR CE marked devices should identify themselves within three months of having first placed a product onto the Swiss market.

Step 3: Register Devices with Swissmedic

Since Switzerland will have no administrative access to EUDAMED, it will have to develop its own registration database. Swissmedic is in the process of building such a platform, but in the meantime, the medical device industry should continue to follow the current registration process. To help with this process, Switzerland will continue to recognize the European CE Marking, including certificates issued by European Notified Bodies.

Increase in Demand

Hopefully using these steps will make the process for placing your medical device or in vitro diagnostic on the Swiss market much clearer. Switzerland is an attractive market for medical devices and In Vitro Diagnostic products with a well-developed healthcare system. The Swiss government is making efforts to improve the access to health care services, especially in the countryside. As such, you can expect that the demand for medical devices will continue to rise in Switzerland over the next few years.

For more information on medical device regulations in Switzerland, visit Swissmedic’s website.

While Swissmedic platform is not currently operational please continue to follow the old registration process. To help with this process MedEnvoy could be hired as either your CH-REP and/or Swiss Importer.

How MedEnvoy can help you meet these requirements:

• • Switzerland Responsible Person (CH-REP) services
  • Switzerland importer services

For more information or questions, contact us!